at Incyte Corporation in Wilmington, Delaware, United States
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Our Global Pharmaceutical Development group is looking for a motivated individual to lead the product development of Incyte's small molecule pipeline.
Essential Functions of the Job (Key responsibilities)
Provide technical expertise on formulating drug products (small molecules). Experience of extended release, pediatric dosage forms a plus.
Working knowledge of solid dosage form equipment and processes
Ability to develop new and innovative formulations, and improve existing ones.
Identify external contract labs, monitors external contracts and reviews batch records.
Work with external contract labs, QA and Process Chemist/Analytical Scientists to implement and execute Formulation strategy, and transferring appropriate manufacturing process for drug products.
Manage junior scientists; provide scientific guidance as needed.
Make recommendations on formulation development and manufacture process.
Write and reviews technical documentation for contributing to regulatory filings.
Works with European, Japanese and global technical operations teams
Assist with creating SOPs relative to formulation and manufacture process.
Qualifications (Minimal acceptable level of education, work experience, and competency)
Must Ph.D. in pharmaceutical sciences or other relevant field.
Minimum of 15 years pharmaceutical R&D experience.
Knowledge of GMP requirements, FDA/ICH guidance and regulatory requirements relative to drug substance characterization and drug product release.
Experience in managing and leading teams.
Strong familiarity of the collection of analytical techniques that support the formulation, fill/finish process development work.
Excellent written and oral communication, including experience delivering professional internal and external presentations.
Strong analytical skills with a demonstrated ability to think strategically.
Knowledge of physical properties, pharmacology, clinical trial supply.
Strong problem-solving skills with a track record of identifying and implementing novel solutions.
Solid negotiation skills in quotation and a persuasive project management style when working with CMO/CRO to achieve company's business and technical objectives.
Transparent and direct communication styles internally and externally.
Able to work in a fast-pace and constantly changing working environment.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
We Respect Your Privacy
Learn more at:
The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .
You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte's data protection practices . By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).
Please contact email@example.com if you have any questions or concerns or would like to exercise your rights.
We appreciate, celebrate, and thrive on one another’s differences and strengths and are proud to be an Equal Opportunity Employer. By valuing diversity of backgrounds and perspectives and prohibiting all forms of harassment, we are able to promote a collaborative and innovative work environment in which everybody can contribute to their fullest potential.